MAUDE Adverse Event Report: RETRACTABLE TECHNOLOGIES, INC. VANISHPOINT®; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Model Number	24331
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/13/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The vanishpoint blood collection set, 21 ga x 3/4" x 12" ref# 24331 the housing can come apart easily if dropped or with the simple use of a fingernail to separate.It is not sealed.Additionally, the button that must be depressed in order to retract the sharp is extremely difficult to depress and requires maneuvering in order to achieve.The clinicians have reported that the item has also had backflow of blood into the area where there is potential to separate along with the sharp becoming a projectile upon depressing the retraction lever.

• Brand Name: VANISHPOINT®
• Common Device Name: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): RETRACTABLE TECHNOLOGIES, INC.; 511 lobo lane; little elm TX 75068
• MDR Report Key: 8631067
• Report Number: 8631067
• Device Sequence Number: 13938456
• Product Code: JKA
• UDI-Device Identifier: 00613703243300
• UDI-Public: (01)00613703243300
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/13/2019
• Report Date (Section F): 05/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 24331
• Device Catalogue Number: 24331
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/22/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 05/13/2019